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A multi-center study for follow-up of complications in women treated by pelvic reconstruction surgery with mesh/native tissue (Part I)

A multi-center study for follow-up of complications in women treated by pelvic reconstruction surgery with mesh/native tissue

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016770
Enrollment
Unknown
Registered
2018-06-23
Start date
2018-06-30
Completion date
Unknown
Last updated
2018-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

female pelvic floor dysfunction

Interventions

laparoscopic sacrocolpopexy/sacrocervicopexy cohort:Patients who prefer to accept laparoscopic sacrocolpopexy/sacrocervicopexy
pelvic reconstruction with trans-vaginal mesh cohort:Patients who prefer to undertake pelvic reconstruction with trans-vaginal mesh
pelvic reconstruction with native tissue cohort:Patients who prefer to accept pelvic reconstruction with native tissue, including high uterosacral ligament suspesion, sacrospinous ligament fixation, i
tension-free vaginal tape surgery to cure stress urinary incontinence cohort:Patients who prefer to accept tension-free vaginal tape surgery to cure stress urinary incontinence

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Women who accepted pelvic floor reconstructive surgeries for POP and/or SUI between November 2017 and December 2022 at 26 tertiary hospitals in China mainland; The surgical indications: (1) Laparoscopic sacrocolpopexy/sacrocervicopexy: Indications: presenting with at least 3 prolapse of the uterus, with or without concomitant cystocele and rectocele; symptomatic stage 2 or greater prolapse of the vaginal vault or apical recurrence, especially having desire of sexual life; (2) Sacrospinous Ligament Fixation, SSLF: Indications: Presenting symptomatic stage 2 or greater prolapse of the uterus, with or without concomitant cystocele and rectocele. The procedure usually is performed after hysterectomy or when the uterus is preserved. (3) High Uterosacral Ligament suspension, HUS. Indications: The same as SSLF; (4) AnteriorPosterior or Total pelvic reconstructive surgery using trans-vaginal mesh (TVM); Indications: Patients experienced recurrence of prolapse in the same compartment that has a history of pelvic floor repair surgery; The choice for elder patients who will accept primary surgery for advanced POP (staging III or IV). (5) Colpocleisis: the Lefort surgery; Indications: Postmenopausal women with advanced uterus or vaginal apex prolapse, and have no desire of sexual life. (6) Anti-urinary incontinence surgeries: tension-free vaginal tape; Indications: Stress urinary incontinence(SUI) patients who have hyperactivity of urethra, or internal urethral sphincter disorder; Or mainly presenting SUI symptoms in patients with mixed urinary incontinence; 2. The failure or recurrence of prolapse the same compartment that has been underwent repair using native tissue.

Exclusion criteria

Exclusion criteria: (1) the recurrence occurred on the same pelvic compartment with a prior history of prolapse repair surgery using mesh, an implant or a graft; (2) a prior history of anti-incontinence surgery using tape; however, patients who are inferred to accept procedures for POP this time are not included; (3) acute/chronic pelvic inflammation, genital tract infections; (4) any severe medical diseases that precluded the operations.

Design outcomes

Primary

MeasureTime frame
Prolapse staging;The CTS coding of postoperative complication;

Secondary

MeasureTime frame
severity of stress urinary incontinence;

Countries

China

Contacts

Public ContactLan Zhu

Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences

zhu_julie@vip.sina.com+86 13718879529

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026